Examples of trials terminated early for commercial reasons
| Study | Reason(s) given for early termination | Concerns raised in the literature |
|---|---|---|
| Randomised controlled trial to assess effects of Pimagedine (aminoguanidine) on early renal disease in insulin-dependent diabetes in Europe2 | Incapacity to “adequately fund and monitor” the study10 | “… patients had been included in a demanding study, exposing some of them to measurement of glomerular filtration rates using labelled tracers and to the uncertain safety profile of a new drug, for no personal or scientific benefit whatsoever”10 |
| Randomised controlled trial comparing liposomal doxorubicin and cyclophosphamide versus epirubicin and cyclophosphamide in metastatic breast cancer4 | The “protocol did not meet the strategic direction in which [the sponsor] wished to develop liposomal doxorubicin.”4 (quoting letter to investigators announcing the termination) | “… the results of the study may never reach enough statistical power to provide a verified scientific answer … patients … may have suffered inconveniences or even contributed their lives to a study now stopped for strategic reasons.”4 |
| Controlled onset verapamil investigation of cardiovascular end points (CONVINCE): “a large, simple trial to assess the equivalence of verapamil to standard therapy in preventing cardiovascular disease related events.”3 | Commercial reasons; decision “did not derive from a recommendation of the data and safety monitoring board, nor from the review of external data from other clinical trials.”3 | “When stopped, the results were still inconclusive with respect to the prespecified equivalence bounds”3 |
| Placebo controlled study of a fluvostatin, Lescol, “for primary prevention of hypercholesterolaemia in men and women aged 70–85 in low cardiovascular risk countries.”1 | “… it was feared that a similar trial of pravastatin in primary and secondary prevention in the elderly would reach its conclusion before the fluvostatin trial … and ‘the internal and external environment had changed around Lescol.’”1 (partially quoting the communication to the steering committee from the sponsor) | This was the first study evaluating the costs and benefits of the use of a fluvostatin in this patient population; early termination placed persons at risk and inconvenience of study participation for no benefit as there were insufficient data to assess the therapy.1 |
| Prospective reinfarction outcomes in the thrombolytic era cardizem CD trial (PROTECT)5 | Commercial reasons5 | None raised by reporting author5 |